diphenhydramine hydrochloride

Generic: diphenhydramine hydrochloride

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name diphenhydramine hydrochloride
Generic Name diphenhydramine hydrochloride
Labeler preferred pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8855
Product ID 68788-8855_9382c976-3067-4923-a38f-101d1c481e97
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-04-11

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888855
Hyphenated Format 68788-8855

Supplemental Identifiers

RxCUI
1049909
UNII
TC2D6JAD40

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name diphenhydramine hydrochloride (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE (68788-8855-0)
  • 15 CAPSULE in 1 BOTTLE (68788-8855-1)
  • 30 CAPSULE in 1 BOTTLE (68788-8855-3)
source: ndc

Packages (3)

68788-8855-0 10 CAPSULE in 1 BOTTLE (68788-8855-0) 68788-8855-1 15 CAPSULE in 1 BOTTLE (68788-8855-1) 68788-8855-3 30 CAPSULE in 1 BOTTLE (68788-8855-3)

Ingredients (1)

diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Diphenhydramine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9382c976-3067-4923-a38f-101d1c481e97", "openfda": {"unii": ["TC2D6JAD40"], "rxcui": ["1049909"], "spl_set_id": ["9382c976-3067-4923-a38f-101d1c481e97"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE (68788-8855-0)", "package_ndc": "68788-8855-0", "marketing_start_date": "20250411"}, {"sample": false, "description": "15 CAPSULE in 1 BOTTLE (68788-8855-1)", "package_ndc": "68788-8855-1", "marketing_start_date": "20250411"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68788-8855-3)", "package_ndc": "68788-8855-3", "marketing_start_date": "20250411"}], "brand_name": "Diphenhydramine Hydrochloride", "product_id": "68788-8855_9382c976-3067-4923-a38f-101d1c481e97", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68788-8855", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine Hydrochloride", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250411", "listing_expiration_date": "20261231"}